Gastric AdenocarcinomaMaGenNCT06902337
Gender Differences in Gastric Cancer Care and Its Adherence to Guidelines in Germany
An observational study of Gastric Adenocarcinoma, run by Medizinische Hochschule Brandenburg Theodor Fontane at 1 site in Germany.
Trial summary
Background: Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While gender differences in gastric cancer care are underexplored in Germany, international studies have revealed disparities in aspects such as histology, co-morbidities, treatment approaches… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma
- How many people
- 75,000 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jul 2025to 30 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A) Cases from the DRG statistics for the years 2017-2021 with inclusion criteria minimum age 18 years, full inpatient hospital treatment in the years 2017-2021, ICD-10-GM code C16, C16.1 - C16.9 B) Cases recorded in a clinical cancer registry from 2017-2021 with ICD-10-GM code C16, C16.1-C16.9
Who may be able to join
- Gastric adenocarcinoma ICD-10-GM code C16, C16.1 - C16.9
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical School Brandenburg
Brandenburg an der Havel, Brandenburg, 14770
About this study
Official title: Gender Differences in Gastric Cancer Care and Its Adherence to Guidelines in Germany: A Observational Retrospective Cohort Study With Administrative Routine and Cancer Registry Data From 2017-2021
Background: Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While gender differences in gastric cancer care are underexplored in Germany, international studies have revealed disparities in aspects such as histology, co-morbidities, treatment approaches, and survival outcomes. This study aims to explore gender-specific variations in clinical management and their impact on mortality, complications, and survival rates in gastric carcinoma patients in Germany.
Methods: This nationwide, retrospective cohort study will analyze data from the German Diagnosis-Related Group statistic and regional clinical cancer registries from 2017 to 2021. The study will evaluate both datasets separately, providing a comprehensive view of gender differences in gastric cancer care. Primary outcomes include hospital mortality and survival rates, while secondary endpoints include surgical complications, treatment modalities, and postoperative outcomes. The analysis will investigate whether gender influences tumor characteristics, access to treatment, and therapy effectiveness. Statistical methods such as descriptive analysis, regression models, and survival analysis will be applied to identify gender-related variations in diagnosis, treatment, and outcomes.
Discussion: By identifying potential gender disparities in diagnosis, treatment, and outcomes, the findings may inform revisions to clinical guidelines and support the development of more personalized treatment strategies. This study aims to improve the quality of care for gastric cancer patients and promote more individualized, sex-sensitive medical practices.
Read the detailed description
Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While there is a lack of current data on gender differences in gastric cancer care in Germany, several international studies conducted on the basis of clinical cancer registry data have pointed to the relevance of this aspect in recent years. The analyses showed significant differences between women and men in aspects such as histology, co-morbidities, operations and therapies performed, and survival rates.
In Germany in 2017, 15,690 people were diagnosed with gastric cancer, of which 6190 were women (39%) and 9490 men (61%). The age-standardized rate of new cases is 7.8 for women and 14.9 for men. The risk of developing the disease increases with age in both sexes; men develop stomach cancer on average at the age of 71 and women at 76 years of age. There are regional differences between the federal states of Germany in all key figures. For example, in the state of Bavaria in 2019, both sexes have an above-average 5-year survival rate of 46.1% for men and 50.7% for women, while in the state of Brandenburg there is a large difference in this ratio between men (38.5%) and women (46.0%).
With regard to hospital mortality in Germany, an analysis of data from the DRG statistics for the years 2009 -2015 showed that the highest mortality rate of 11.7% was observed in patients undergoing visceral surgery in complex gastric surgery (in comparison, average hospital mortality among patients undergoing visceral surgery: 1.9%).
The aim of the project is to use routine data of the DRG statistic and data from the clinical cancer registries of the federal states to determine whether there are differences between women and men in the clinical care of gastric carcinomas and whether such different care has an impact on the mortality rate, complications and survival time of those affected.
Data from the hospital statistics (DRG statistics) and data from the clinical cancer registries are used as the data basis for the above-mentioned research questions and evaluated separately from each other.
In a first step, it will be investigated whether and to what extent women and men already differ in tumor characteristics (diagnosis, localization, histology, UICC stage, etc.) and in possible co-morbidities and co-variates such as age.
In a second step, the therapy (surgical procedures, oncological therapies) is analyzed under the focus variable gender. The aim here is to analyze whether women and men receive the same therapies if, for example, the tumor characteristics have the same tumor characteristics, or whether there are differences in both access and type of therapies.
In a third step, both the influence of the tumor characteristics and the therapies used on the outcome of the therapies will be investigated under gender-specific aspects. These include, for example, complications after surgery, side effects of oncological therapies, length of hospital stay, hospital mortality or long-term survival. It is of particular interest here whether there are particularly successful therapeutic strategies depending on gender and diagnosis with regard to the above-mentioned outcome parameters, i.e. whether there is a need to treat women and men differently if, for example, the tumor characteristics have the same tumor characteristics.
Since both analyses complement each other in their statements, the project can thus provide a comprehensive picture of gender-specific care in Germany. Furthermore, the project results provide a scientific data basis for a possible revision of the S3 guideline for the treatment of gastric cancer as well as for medical education and training.
- Conditions
- Gastric Adenocarcinoma
- Keywords
- Gastric cancer, Sex differences, Clinicopathological characteristics, Treatment, Mortality, Survival, Treatment guidelines, Administrative routine data, Cancer registry data
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with gastric adenocarcinoma | Gastric carcinoma (ICD-10-GM C16) Patients with gastric carcinoma in the years 2017-2021 in Germany, minimum age 18 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
DRG statistic: in-hospital mortality
Death in hospital after treatment in days
Measured: 2017-2021
Cancer registry: 1 and 3 year survival
Survival after diagnosis date in months
Measured: 2017-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start31 Jul 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 75,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rene Mantke, Medizinische Hochschule Brandenburg Theodor Fontane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902337
- Sponsor's protocol ID
- MaGen (01VSF24051)
- Other IDs
- 01VSF24051
- Acronym
- MaGen
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data protection
Publications
Weber U, Kress L, Hunger R, Schildberg C, Mantke R. Gender differences in gastric cancer care and its adherence to guidelines in Germany (MaGen): protocol for an observational retrospective cohort study with administrative routine and cancer registry data from 2017 to 2021. BMJ Open. 2026 Feb 2;16(2):e103467. doi: 10.1136/bmjopen-2025-103467.
PubMed 41628928
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in Gastric Cancer Care and Its Adherence to Guidelines in Germany: A Observational Retrospective Cohort Study With Administrative Routine and Cancer Registry Data From 2017-2021
- ClinicalTrials.gov ID
- NCT06902337
- Acronym / sponsor ID
- MaGen / MaGen (01VSF24051)
- Conditions
- Gastric Adenocarcinoma
- Keywords
- Gastric cancer, Sex differences, Clinicopathological characteristics, Treatment, Mortality, Survival, Treatment guidelines, Administrative routine data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75,000 participants (actual)
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor FontaneUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While gender differences in gastric cancer care are underexplored in Germany, international studies have revealed disparities in aspects such as histology, co-morbidities, treatment approaches, and survival outcomes. This study aims to explore gender-specific variations in clinical management and their impact on mortality, complications, and survival rates in gastric carcinoma patients in Germany.
Methods: This nationwide, retrospective cohort study will analyze data from the German Diagnosis-Related Group statistic and regional clinical cancer registries from 2017 to 2021. The study will evaluate both datasets separately, providing a comprehensive view of gender differences in gastric cancer care. Primary outcomes include hospital mortality and survival rates, while secondary endpoints include surgical complications, treatment modalities, and postoperative outcomes. The analysis will investigate whether gender influences tumor characteristics, access to treatment, and therapy effectiveness. Statistical methods such as descriptive analysis, regression models, and survival analysis will be applied to identify gender-related variations in diagnosis, treatment, and outcomes.
Discussion: By identifying potential gender disparities in diagnosis, treatment, and outcomes, the findings may inform revisions to clinical guidelines and support the development of more personalized treatment strategies. This study aims to improve the quality of care for gastric cancer patients and promote more individualized, sex-sensitive medical practices.
Detailed description
Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While there is a lack of current data on gender differences in gastric cancer care in Germany, several international studies conducted on the basis of clinical cancer registry data have pointed to the relevance of this aspect in recent years. The analyses showed significant differences between women and men in aspects such as histology, co-morbidities, operations and therapies performed, and survival rates.
In Germany in 2017, 15,690 people were diagnosed with gastric cancer, of which 6190 were women (39%) and 9490 men (61%). The age-standardized rate of new cases is 7.8 for women and 14.9 for men. The risk of developing the disease increases with age in both sexes; men develop stomach cancer on average at the age of 71 and women at 76 years of age. There are regional differences between the federal states of Germany in all key figures. For example, in the state of Bavaria in 2019, both sexes have an above-average 5-year survival rate of 46.1% for men and 50.7% for women, while in the state of Brandenburg there is a large difference in this ratio between men (38.5%) and women (46.0%).
With regard to hospital mortality in Germany, an analysis of data from the DRG statistics for the years 2009 -2015 showed that the highest mortality rate of 11.7% was observed in patients undergoing visceral surgery in complex gastric surgery (in comparison, average hospital mortality among patients undergoing visceral surgery: 1.9%).
The aim of the project is to use routine data of the DRG statistic and data from the clinical cancer registries of the federal states to determine whether there are differences between women and men in the clinical care of gastric carcinomas and whether such different care has an impact on the mortality rate, complications and survival time of those affected.
Data from the hospital statistics (DRG statistics) and data from the clinical cancer registries are used as the data basis for the above-mentioned research questions and evaluated separately from each other.
In a first step, it will be investigated whether and to what extent women and men already differ in tumor characteristics (diagnosis, localization, histology, UICC stage, etc.) and in possible co-morbidities and co-variates such as age.
In a second step, the therapy (surgical procedures, oncological therapies) is analyzed under the focus variable gender. The aim here is to analyze whether women and men receive the same therapies if, for example, the tumor characteristics have the same tumor characteristics, or whether there are differences in both access and type of therapies.
In a third step, both the influence of the tumor characteristics and the therapies used on the outcome of the therapies will be investigated under gender-specific aspects. These include, for example, complications after surgery, side effects of oncological therapies, length of hospital stay, hospital mortality or long-term survival. It is of particular interest here whether there are particularly successful therapeutic strategies depending on gender and diagnosis with regard to the above-mentioned outcome parameters, i.e. whether there is a need to treat women and men differently if, for example, the tumor characteristics have the same tumor characteristics.
Since both analyses complement each other in their statements, the project can thus provide a comprehensive picture of gender-specific care in Germany. Furthermore, the project results provide a scientific data basis for a possible revision of the S3 guideline for the treatment of gastric cancer as well as for medical education and training.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with gastric adenocarcinoma | – | –Gastric carcinoma (ICD-10-GM C16) Patients with gastric carcinoma in the years 2017-2021 in Germany, minimum age 18 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A) Cases from the DRG statistics for the years 2017-2021 with inclusion criteria minimum age 18 years, full inpatient hospital treatment in the years 2017-2021, ICD-10-GM code C16, C16.1 - C16.9 B) Cases recorded in a clinical cancer registry from 2017-2021 with ICD-10-GM code C16, C16.1-C16.9
Key inclusion criteria (1 listed)
- Gastric adenocarcinoma ICD-10-GM code C16, C16.1 - C16.9
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DRG statistic: in-hospital mortality
Time frame: 2017-2021
Death in hospital after treatment in days
Cancer registry: 1 and 3 year survival
Time frame: 2017-2021
Survival after diagnosis date in months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 41628928Weber U, Kress L, Hunger R, Schildberg C, Mantke R. Gender differences in gastric cancer care and its adherence to guidelines in Germany (MaGen): protocol for an observational retrospective cohort study with administrative routine and cancer registry data from 2017 to 2021. BMJ Open. 2026 Feb 2;16(2):e103467. doi: 10.1136/bmjopen-2025-103467.
- Individual participant dataSharing planned: No. Due to data protection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Adenocarcinoma, run by Medizinische Hochschule Brandenburg Theodor Fontane at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DRG statistic: in-hospital mortality (time frame: 2017-2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06902337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.